The FDA: AI credibility becomes regulatory reality

By Dr Nicola Davies

On January 6, 2025, the US Food and Drug Administration (FDA) issued draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products.” The guidance outlines the FDA’s expectations for the use of AI in supporting regulatory assessments of safety, effectiveness, and quality.

Issued as a request for comment, the draft marks a shift from broad encouragement of AI-enabled innovation toward more explicit regulatory expectations. In doing so, the FDA signals a move toward a risk-based, credibility-focused framework that sponsors will be expected to apply when using AI to inform regulatory decisions.